Peri-capsular Nerve Group Block and Quadratus Lumborum Block for Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark
研究概览
简要总结
The goal of this randomized controlled clinical trial is to compare peri-capsular nerve group (PENG) block and quadratus lumborum (QL) block in participants who receive hip arthroplasty. The main question aims to answer is comparing the pain score among participants who receive PENG or QL block.
Participants will be randomized and assigned into two groups. Participants will receive a PENG block in the PENG group and receive a QL block in the QL group. After participants receive hip arthroplasty, the investigators will compare the two groups to see if there is a difference of pain score, postoperative opioid consumption, sensation and motor function after nerve blocks, progress of functional recovery in lower limbs, intraoperative and postoperative complications.
详细描述
Hip joint surgery is a common orthopedic procedure that effectively improves patients' quality of life and functional status. However, postoperative pain is a common issue that can affect patients' activity, increase the risk of venous thromboembolism due to venous stasis, and prolong recovery time, hospital stay, and expenses. Therefore, controlling postoperative pain after hip joint surgery is crucial to reduce its side effects. Nerve block is one of the methods for postoperative pain management after hip joint surgery and has been proven effective in reducing pain levels, decreasing opioid use, and its side effects.
Traditionally, the quadratus lumborum nerve block (QL block) is used for pain relief during abdominal surgery, but it can also be used for lower limb surgery due to its extensive application. Compared to other nerve blocks, QL block may provide better postoperative pain relief, have less impact on hip joint activity and quadriceps muscle contraction, and reduce opioid use and hospital stay.
The peri-capsular nerve group block (PENG block) is another nerve block technique performed by injecting anesthetic analgesics around the hip joint capsule using ultrasound and blocking surrounding nerves with a larger dose. In a clinical study, PENG block significantly reduced static and dynamic pain scores in five patients with femoral neck fractures after 30 minutes of the nerve block. PENG block has advantages in injection and identification of anatomical structures compared to QL block, but their analgesic effects have not been directly compared. Therefore, clinical trials of both techniques are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will not know which group they are in. Care provider, investigator, and outcomes assessor does not know which block participants will receive. The anesthesiologists who perform the blocks are not care provider, investigator, or outcomes assessor.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are 20 years of age or older (including 20 years of age).
- •Non-emergency hip arthroplasty surgery.
- •Able to understand and cooperate with preoperative and postoperative data collection.
- •Grade one to three in the American Society of Anesthesiologists (ASA) physical status classification.
排除标准
- •Under 20 years of age.
- •A known allergy to the study medication (ropivacaine).
- •Liver cirrhosis classified as Child Pugh Score C.
- •Dementia or mental illness.
- •Unable to assess their own pain level.
- •Patients who have been using opioid drugs for a prolonged period.
- •Having a history of drug or alcohol abuse within the last 6 months.
- •Having serious illness and at a risk of imminent mortality.
结局指标
主要结局
Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark
时间窗: at the 48-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups at the 12-hour postoperative mark
时间窗: at the 12-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups immediately after surgery
时间窗: 10 minutes after surgery
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups at the 1-hour postoperative mark
时间窗: at the 1-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
Comparing pain scores between the PENG and QL groups at the 24-hour postoperative mark
时间窗: at the 24-hour postoperative mark
Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.
次要结局
- Time to walk with the aid of walking devices after surgery(From the date of hip surgery until the patient achieves walking with the aid of walking devices, with a maximum follow-up period of 7 days)
- Perioperative blood loss and blood transfusion(During the surgery and over the three-day postoperative period)
- Postoperative opioid consumption(at the 12-, 24-, 48-hours after surgery)
- The quadriceps strength on surgical side(at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery)
- Time to independently sit at the edge of the bed after surgery(From the date of hip surgery until the patient achieves independent sitting at the edge of the bed, with a maximum follow-up period of 7 days)
- Time to stand up after surgery(From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days)
研究者
Po-Kai Wang
Director, Division of Pain Management, Department of Anesthesiology
Hualien Tzu Chi General Hospital